EVALUATION OF EFFECTS OF N- ACETYL CYSTEINE ON THE PREVENTION OF LIVER INJURY AND QUALITY OF LIFE IN PATIENTS TAKING TREATMENT FOR TUBERCULOSIS.

Not Applicable

• Conditions: Health Condition 1: A150- Tuberculosis of lung

• Registration Number: CTRI/2020/05/024995
• Lead Sponsor: Dr Deepasree Sukumaran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Newly diagnosed with pulmonary or extrapulmonary tuberculosis based on symptoms, radiological features and/or laboratory evidence and requiring first line ATT.

2.LFT values less than or equal to 3 times of the normal reference values (SGOT less than or equal to 105 U/L, SGPT less than or equal to 120 U/L, ALP less than or equal to 390 U/L) and Total bilirubin less than or equal to 2 mg/dl).

3. Subjects who agree to comply with the study procedures

Exclusion Criteria

1.Pregnant and lactating women.

2.History of hypersensitivity to the study drug.

3.Subjects with history of liver disease, kidney disease, COPD, asthma and HIV.

4.History of chronic smoking or chronic alcoholism.

5.Patients on any concomitant medications known to affect hepatic function within the past 3 months.

6.Patients with any comorbidities that is known to affect the study outcome.

7.Patients with any contraindications to the study medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Comparison of proportion of patients developing DILI between treatment and control groups. (DILI defined as per ATS criteria). <br/ ><br> <br/ ><br>2.Change in oxidative stress markers (Malondialdehyde, Nitric oxide and total glutathione levels) from baseline.Timepoint: 0 weeks, 2 weeks, 4 weeks, 8 weeks.

Secondary Outcome Measures

Name	Time	Method
1.Comparison of the quality of life between treatment and control group using SF â?? 12 questionnaire. <br/ ><br>2.Comparison of time to development of DILI between treatment and control groups. <br/ ><br>3.Incidence of adverse effects in the study population.Timepoint: 0 weeks, 2 weeks, 4 weeks, 8 weeks.